Visually-Based Diagnostic Device for Automatic Determination of a Physiologic Level Associated with a Sample

Abstract

Diagnostic devices; systems, methods and computer-readable media store instructions related to determining hemoglobin information using those devices. The methods may include processing a captured image of the reservoir and/or device and the device information to determine color information for the solution and the scale, the color information including one or more color attributes; adjusting the color information for the solution based on the color information for the scale; and determining hemoglobin information (e.g., hemoglobin level, disease state and/or calculated hematocrit) based on the adjusted color information and a stored profile information associated with the device information.

1 . A device comprising:
 a cap including a collection member configured to collect a biological sample and one or more members surrounding the collection member, the cap including one or more coupling members; and   a body including a reservoir configured to be filled with a solution and an information member, the information member at least demarcating an analysis region, the analysis region corresponding to a defined area of the body in which at a portion of the reservoir is visible, the body including one or more complimentary members configured to receive the coupling members of the cap and the reservoir being configured to receive the collection member and the one or more members surrounding the collection member.   
     
     
         2 . The device according to  claim 1 , wherein the body includes a seal disposed above the reservoir and the one or more members surrounding the collection member are configured to break the seal. 
     
     
         3 . The device according to  claim 1 , wherein the information member further includes identification information, the information member including one or more legends or scales representing one or more colors configured to correct an image of the analysis region for lighting conditions. 
     
     
         4 . The device according to  claim 1 , wherein the body and the cap are configured to be mated and to be flush when mated. 
     
     
         5 . The device according to  claim 4 , wherein the cap includes one or more tapered protruding members that surround the collection member. 
     
     
         6 . The device according to  claim 3 , wherein the information member is disposed on an outer surface of the body. 
     
     
         7 . The device according to  claim 1 , wherein the body is circular or rectangular. 
     
     
         8 . The device according to  claim 1 , wherein the body is at least partially transparent. 
     
     
         9 . The device according to  claim 1 , wherein the reservoir is an elongated channel. 
     
     
         10 . The device according to  claim 9 , wherein the reservoir is disposed between the one or more coupling members. 
     
     
         11 . A method of determining hemoglobin information for a collected biological sample from a diagnostic, screening or risk-assessment device, the device including an analysis region for a reservoir containing a pre-filled solution mixed with the biological sample and an information member including one or more scales, comprising:
 processing a captured image of the analysis region and the device information to determine color information for the analysis region and one or more scales, the color information including a quantitative value representing one or more color attributes;   correcting the color information for the solution based on the color information for the scale; and   determining hemoglobin information based on the adjusted color information and stored profile information associated with the device.   
     
     
         12 . The method according to  claim 11 , further comprising:
 selecting the profile information from a plurality of stored profile information based on the device information, the profile information including a standardized scale for the solution.   
     
     
         13 . The method according to  claim 11 , wherein the one or more color attributes include intensity, brightness, hue, among others, or a combination thereof. 
     
     
         14 . The method according to  claim 11 , wherein the processing includes processing the image to determine proper orientation and distance based on one or more reference members provided on the device. 
     
     
         15 . The method according to  claim 11 , wherein the determining the hemoglobin information includes correlating the adjusted color information to the stored profile information, the stored profile information including a three-dimensional plane associating color information associated with the solution and hemoglobin levels. 
     
     
         16 . The method according to  claim 11 , further comprising:
 displaying the hemoglobin information.   
     
     
         17 . The method according to  claim 11 , wherein the collected biological sample is blood collected with a sample tube included with the device. 
     
     
         18 . The method according to  claim 11 , wherein the hemoglobin information includes a hemoglobin value, a calculated or direct hematocrit value, and/or a disease state associated with the hemoglobin value and/or hematocrit value. 
     
     
         19 . The method according to  claim 11 , wherein the one more scales correct the captured image for lighting conditions. 
     
     
         20 . The method according to  claim 11 , further comprising:
 causing a camera to capture an image of the device, the device including the analysis region and the information member; and   receiving the image of the device.